Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care

Abstract

Background The US continues to face public health crises related to both chronic pain and opioid overdoses. Thirty percent of Americans suffer from chronic noncancer pain at an estimated yearly cost of over $600 billion. Most patients with chronic pain turn to primary care clinicians who must choose from myriad treatment options based on relative risks and benefits, patient history, available resources, symptoms, and goals. Recently, with attention to opioid-related risks, prescribing has declined. However, clinical experts have countered with concerns that some patients for whom opioid-related benefits outweigh risks may be inappropriately discontinued from opioids. Unfortunately, primary care clinicians lack usable tools to help them partner with their patients in choosing pain treatment options that best balance risks and benefits in the context of patient history, resources, symptoms, and goals. Thus, primary care clinicians and patients would benefit from patient-centered clinical decision support (CDS) for this shared decision-making process. Methods The objective of this 3-year project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in new clinical settings in the OneFlorida Clinical Research Consortium. Our central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making. We further hypothesize that increases in shared decision making will lead to improved patient outcomes, specifically pain and physical function. The CDS implementation will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. The evaluation will be organized by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We will adapt and tailor PainManager, an open source interoperable CDS tool, for implementation in primary care clinics affiliated with the OneFlorida Clinical Research Consortium. We will evaluate the effect of tailored implementation support on PainManager’s adoption for pain treatment shared decision making. This evaluation will establish the feasibility and obtain preliminary data in preparation for a multi-site pragmatic trial targeting the effectiveness of PainManager and tailored implementation support on shared decision making and patient-reported pain and physical function. Discussion This research will generate evidence on strategies for implementing interoperable CDS in new clinical settings across different types of electronic health records (EHRs). The study will also inform tailored implementation strategies to be further tested in a subsequent hybrid effectiveness-implementation trial. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions. Trial registration ClinicalTrials.gov, NCT05256394, Registered 25 February 2022.

Expectation and acceptance of clinical decision support systems: A survey study among nephrologist end-users

“…In recent years, a growing number of mobilehealth technology in the management of chronic diseases has been observed [33,34]. These applications are mainly aimed at patients as end-users and primarily achieve pure data collection [35]. The integration of data accumulated through these apps in clinical nephrology practices is limited by: 1.…”

Methodological progress note: Hybrid effectiveness‐implementation clinical trials

“… A Type 2 hybrid trial has a dual focus on intervention effectiveness and implementation outcomes (e.g., Gilmartin et al's 14 evaluation of the effectiveness of the rural transitions nurse program; Hassett et al's 15 implementation of patient‐reported outcomes for symptom management in oncology practice). A Type 3 hybrid trial focuses primarily on implementation outcomes while also exploring effectiveness outcomes as they relate to uptake, integration, and fidelity of the intervention in real‐world settings (e.g., Bonafide et al's 16 evaluation of a safety huddle‐based intervention; Salloum et al's 17 evaluation of clinical decision support for patient‐centered chronic pain management). …”

“…A Type 3 hybrid trial focuses primarily on implementation outcomes while also exploring effectiveness outcomes as they relate to uptake, integration, and fidelity of the intervention in real‐world settings (e.g., Bonafide et al's 16 evaluation of a safety huddle‐based intervention; Salloum et al's 17 evaluation of clinical decision support for patient‐centered chronic pain management).…”

“…Hybrid trials exist on a continuum, with the three designs varying based on their primary focus and the amount of emphasis on effectiveness versus implementation outcomes (see Table 1 and Figure 1) 11 , 12 : A Type 1 hybrid trial focuses primarily on the intervention effectiveness outcomes while exploring the context for future intervention implementation (e.g., Wooldridge et al's 10 evaluation of nonadherence in patients who received discharge medication counseling by a pharmacist as part of an RCT; Naef et al 13 evaluation of a multicomponent family support intervention in intensive care settings). A Type 2 hybrid trial has a dual focus on intervention effectiveness and implementation outcomes (e.g., Gilmartin et al's 14 evaluation of the effectiveness of the rural transitions nurse program; Hassett et al's 15 implementation of patient‐reported outcomes for symptom management in oncology practice). A Type 3 hybrid trial focuses primarily on implementation outcomes while also exploring effectiveness outcomes as they relate to uptake, integration, and fidelity of the intervention in real‐world settings (e.g., Bonafide et al's 16 evaluation of a safety huddle‐based intervention; Salloum et al's 17 evaluation of clinical decision support for patient‐centered chronic pain management).…”

Examining primary care provider experiences with using a clinical decision support tool for pain management

“…Ultimately, CDS focused on chronic pain could support PCPs in providing safer and more patient-centered care for patients. 11 While quantitative evaluations of existing chronic pain CDS tools exist, 12–14 current work does not assess PCPs’ experience and behavior with adopting and using chronic pain CDS tools. Qualitative evaluations support the thorough examination of factors associated with CDS uptake and use, as most CDS tools target user behavior.…”